Phase 3
N=1,208
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm E (Fluvoxamine 100)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT05894564 ↗Enrolled (actual)
1,208
Serious AEs
0.6%
Results posted
Feb 2024
Primary outcome: Primary: Time to Sustained Recovery in Days — 10; 10 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluvoxamine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Susanna Naggie, MD
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Recovery in Days |
10; 10 | — |
| SECONDARY Number of Participants With Hospitalization or Death |
1; 2 | — |
| SECONDARY Number of Participants With Mortality |
0; 0 | — |
| SECONDARY Time to Mortality |
— | — |
| SECONDARY Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death |
14; 21 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7. |
55; 37; 472; 504; 24; 25 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14. |
39; 36; 490; 500; 12; 22 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28. |
37; 28; 488; 502; 12; 14 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function |
20; 20; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue |
8; 8; 6; 5; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Pain |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Depression |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Social |
19; 20; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep |
9; 9; 8; 8; 8; 8 | — |
| SECONDARY Time Unwell in Days as Measured by the Symptom and Clinical Event Scale |
11.28; 11.45 | — |
| SECONDARY Mean Days Benefit as Measured by the Symptom and Clinical Event Scale |
3.52; 3.32 | — |
Summary
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
Eligibility Criteria
Inclusion Criteria
- Completed Informed Consent
- Age ≥ 30 years old
- Confirmed SARS-CoV-2 infection (or reinfection) by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
- Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria
- Prior diagnosis of COVID-19 infection (> 10 days from screening)
- Current or recent (within 10 days of screening) hospitalization
- Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
- Known contraindication(s) to study drug including prohibited concomitant medications
Additional Appendix-Level Exclusion Criteria
- Use of selective serotonin (or norepinephrine) reuptake inhibitors (SSRIs/SNRIs), including fluvoxamine, or monoamine oxidase inhibitors (MAOIs) within 2 weeks of consent including triptans and tryptophan. Use of fluoxetine within 45 days of consent.
- Co-administration of tizanidine, thioridazine, alosetron, pimozide, diazepam, ramelteon, linezolid
- Bipolar Disorder
- Nursing mothers
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT05894564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.